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Group seeks greater diversity in clinical research

Thursday, October 1, 2015

First of two parts

In 2006, a trial led to a “black box warning label” for an asthma medi­cation found to have a disproportion­ally increased death rate. It revealed that respiratory-related deaths oc­curred four times more often in Af­rican-Americans who took the drug.

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Regulatory Update, October 2015

Thursday, October 1, 2015

FDA Issues Several Draft Guidance Documents

Since the last issue, FDA released six draft guidance documents in the Federal Register. Interested persons should submit electronic or written comments on draft FDA guidance documents by the date specified (in parentheses) to have their comments considered for preparation of the final document, but comments will be accepted at any time and may be used in the future. Submit comments as instructed above. Identify comments with the associated Docket number (also in parentheses).

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Regulatory Update, September 2015

Tuesday, September 1, 2015

FDA Draft Guidance on Male-Mediated Developmental Risks for Pharmaceuticals

In the June 12, 2015 Federal Regis­ter, FDA announced the availability of a draft guidance titled Assessment of Male-Mediated Developmental Risk for Phar­maceuticals. This draft guidance provides recommendations to sponsors for assess­ing risks to embryo/fetal development re­sulting from administration of an active pharmaceutical ingredient (API) to males either through an effect on the male germ cell or from fetal exposure following semi­nal transfer of a potentially developmental toxicant to pregnant females. The need for measures to mitigate the risk to embryo/fetal development posed by males partici­pating in clinical trials also is addressed.

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